The European Commission has officially proposed extended transition timelines for legacy devices under Regulation (EU) 2017/745 on medical devices (MDR).
Please note that this is a proposal and still must be adopted before it becomes legally valid.
The proposal defines new transition timelines:
31 December 2027, for class III devices and for class IIb implantable devices, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors;
31 December 2028, for class IIb devices other than those covered by point (a), for class IIa devices, and for class I devices placed on the market in sterile condition or having a measuring function;
31 December 2028, for class I devices that need notified body involvement due to amended MDR classification rules (e.g. reusable surgical instruments).
The proposal also provides some conditions that must be fulfilled to make use of the new timelines. Below you will find the most important points:
(a) devices continue to comply with Directive 90/385/EEC or Directive 93/42/EEC, as applicable;
(b) there are no significant changes in the design and intended purpose;
(c) devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health;
(d) no later than 26 May 2024, the manufacturer has put in place a quality management system in accordance with Article 10(9);
(e) no later than 26 May 2024, the manufacturer, or an authorised representative, has lodged a formal application in accordance with Section 4.3, first subparagraph, of Annex VII for conformity assessment in respect of a device referred to in paragraphs 3b and 3c of this Article or in respect of a device intended to substitute that device, and no later than 26 September 2024 the notified body and the manufacturer have signed a written agreement in accordance with Section 4.3, second subparagraph, of Annex VII.
Please note that still in parallel, manufacturers of legacy devices must already comply with the MDR requirements on PMS, vigilance, registration and market surveillance.
Furthermore, for manufacturers of legacy devices with an MDD/ AIMDD notified body certificate, the certificate must be valid by the date of adoption of the proposal. If this is not the case, i.e. if the certificate expired before the adoption date, the following conditions must be fulfilled in addition:
(a) before the date of expiry of the certificate, the manufacturer and a notified body have signed a written agreement in accordance with Section 4.3, second subparagraph, of Annex VII for the conformity assessment in respect of the device covered by the expired certificate or in respect of a device intended to substitute that device;
(b) a competent authority of a Member State has granted a derogation from the applicable conformity assessment procedure in accordance with Article 59(1) or has required the manufacturer, in accordance with Article 97(1), to carry out the applicable conformity assessment procedure’.
As a final point, the proposal suggests to suspend the sell-off period for devices that have already been placed on the market before the date of application of the Regulations.
Stakeholders may provide feedback to the proposal until January 18, so it is anticipated that the Commission seeks a timely finalization of the process.
Please let us know should you require additional details.
Source: European Commission
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